Table 3.

Summary of treatment regimen and toxicity for patients receiving gene-modified T cells

PatientCycle no.No. T cells × 10−9No. IL-2 injectionsGrades of adverse eventsGrade 1 and 2 toxicity eventsGrade 3 and 4 toxicity events
113.061, 2, 3, 4HB, FAT, NAU, PU, PELEU, HYP, PCD
23.0*52, 3EDRIG
310.032, 3ED, LEU, PCD, PU, PEHB, HYP
213.051, 2PCD, FAT, NAU, BIL, PU
29.04
347.04
313.053DIA, FAT
210.032LUO
317.513HYP, STC
413.05
211.413DYS
321.90
513.032ASC
6128.5762FAT, DIA
211.062FAT
7122.002, 4RIG, VOMDYS
8144.023HYP
243.512DYS
Cycle no.
No. T cells × 10−9
No. allo immunizations§
No. allo cells × 10−9
Grades of adverse events
Grade 1 and 2 toxicity events
9146.524.551, 2ISR, URT, DYS
2169.026.5None
10113.1724.51, 2RIG, ISR, NAU
250.027.0None
1114.027.82ISR
12111.727.321ISR
13136.726.72None
1419.027.451, 2HYP, RIG, FAT, ISR, NAU, VOM
  • Abbreviations: ASC, ascites; HB, hemoglobin; PE, pleural effusion; BIL, bilirubin increased; HYP, hypotension; PU, pulmonary; DIA, diarrhea; LEU, leukopenia; RIG, rigors; DYS, dyspnea; LUO, low urine output; STC, sinus tachycardia; ED, Edema; NAU, nausea; URT, urticaria; FAT, fatigue; PCD, platelet count decreased; VOM, vomiting; ISR, injection site reaction (allogeneic immunization).

  • * No progression to higher dose in this cycle due to grade 4 toxicity in previous cycle.

  • Some of these cells were labeled with 111In for trafficking.

  • Off protocol after one cycle due to dyspnea concerns.

  • § Dose divided into two to four injections given on day 1 and 8 following MOv-γ T cells.